A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants

NCT06729970
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Phase
Phase 1
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Recruitment status
Completed
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Participants
133
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Lead sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
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Start date
2024-12-26
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Number of sites
1
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Summary
The purpose of this study is to evaluate the effects of lithium, valproic acid, and lamotrigine on the single-dose pharmacokinetics (PK) of KarXT and the effect of KarXT on the single-dose PK of lithium, valproic acid, and lamotrigine in healthy participants.
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Short title
A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants
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Official title
A Phase 1, 6-part, Open-label, Fixed-sequence Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Single-dose Pharmacokinetics of KarXT and Effects of KarXT on the Single-dose Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2026-01-23
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First posted
2024-12-12
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Registry last updated
2026-02-24
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Primary completion date
2026-01-23
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Start date
2024-12-26
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Actual participants
133
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Participants
133
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06729970
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ClinicalTrials.gov ID
NCT06729970
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Maximum observed plasma concentration (Cmax)

    Timeframe: Up to day 54

  2. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Timeframe: Up to day 54

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

    Timeframe: Up to day 54

  1. Number of participants with adverse events (AEs)

    Timeframe: Up to 28 days post discontinuation of dosing

  2. Number of participants with serious adverse events (SAEs)

    Timeframe: Up to 28 days post discontinuation of dosing

  3. Number of participants with physical examination abnormalities

    Timeframe: Up to 2 days post discontinuation of dosing

  4. Number of participants with vital sign abnormalities

    Timeframe: Up to 2 days post discontinuation of dosing

  5. Number of participants with 12-lead electrocardiogram (ECG) abnormalities

    Timeframe: Up to 2 days post discontinuation of dosing

  6. Number of participants with clinical laboratory abnormalities

    Timeframe: Up to 2 days post discontinuation of dosing

  7. Columbia-Suicide Severity Rating Scale (C-SSRS)

    Timeframe: Up to 2 days post discontinuation of dosing

  8. Number of participants with AEs of Special Interest (AESIs)

    Timeframe: Up to 28 days post discontinuation of dosing

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
Yes

  • Healthy male and female [individual not of childbearing potential (INOCBP)] participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, vital signs, and clinical laboratory determinations.
  • BMI of 18.0 to 32.0 kg/m2, inclusive.

  • History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. Note: Any grade of hepatic impairment (Child-Pugh Grade A or higher) is excluded.
  • Parts B and D only: History of pancreatitis.
  • Any significant acute or chronic medical illness, in the opinion of the investigator.
  • History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma or known history of prostate hypertrophy or nocturia.
  • Parts E & F only: history of skin rash and mucus ulcerations of no obvious cause and Gilbert's syndrome
  • Other protocol-defined Inclusion/Exclusion criteria apply.
Sources for eligibility
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  • Local Institution - 0001Los Alamitos, United States
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (5)

Lead sponsors (1)

Targets (27)